Trial Outcomes & Findings for Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding (NCT NCT01821326)
NCT ID: NCT01821326
Last Updated: 2017-01-25
Results Overview
Recruitment status
COMPLETED
Target enrollment
339 participants
Primary outcome timeframe
10 years
Results posted on
2017-01-25
Participant Flow
Participant milestones
| Measure |
Patients With Obscure Gastrointestinal Bleeding
|
|---|---|
|
Overall Study
STARTED
|
339
|
|
Overall Study
COMPLETED
|
339
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
Baseline characteristics by cohort
| Measure |
Patients With Obscure Gastrointestinal Bleeding
n=339 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
200 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
139 Participants
n=99 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 18.4 • n=99 Participants
|
|
Gender
Female
|
162 Participants
n=99 Participants
|
|
Gender
Male
|
177 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
339 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 10 yearsOutcome measures
| Measure |
Patients With Obscure Gastrointestinal Bleeding
n=339 Participants
|
|---|---|
|
Rebleeding Rate
|
97 participants
|
Adverse Events
Patients With Obscure Gastrointestinal Bleeding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Obscure Gastrointestinal Bleeding
n=339 participants at risk
|
|---|---|
|
Gastrointestinal disorders
capsule endoscopy retention
|
0.00%
0/339 • 10 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place